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Contract research organization

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In the life sciences, a contract research organization or clinical research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and real world evidence.

Clinical trialClinical trialPhase of clinical research in medicineA clinical trial participant receives an injection.Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison.Outcomes researchOutcomes researchOutcomes research is a branch of public health research which studies the end results () of the structure and processes of the health care system on the health and well-being of patients and populations. According to one medical outcomes and guidelines source book - 1996, Outcomes research includes health services research that focuses on identifying variations in medical procedures and associated health outcomes.Pharmaceutical industryPharmaceutical industryIndustry involved with discovery, development, production and marketing of drugsA drug manufacturer inspection by the US Food and Drug AdministrationThe pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications. Medications are then administered to (or self-administered by) patients for curing or preventing disease or for alleviating symptoms of illness or injury.OutsourcingOutsourcingContracting internal tasks to an external organizationWorldwide communication allowed customer service interactions to be outsourced to low-wage countries, particularly in call centers.Outsourcing is a business practice in which companies use external providers to carry out business processes that would otherwise be handled internally.Niche marketNiche marketA niche market is the subset of the market on which a product is appealed to a small group of consumers. The market niche defines the product features aimed at satisfying specific market needs, as well as the price range, production quality and the demographics that it is intended to target. It is also a small market segment. Sometimes, a product or service can be entirely designed to satisfy a niche market. Not every product can be defined by its market niche.Real world evidenceReal world evidenceReal-world evidence (RWE) in medicine is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and retrospective or prospective observational studies.BiotechnologyBiotechnologyField of science that uses cells for the creation of productsA biologist conducting research in a biotechnology laboratoryBiotechnology is a multidisciplinary field that involves the integration of natural sciences and engineering sciences to achieve the application of organisms and parts thereof for products and services. The term biotechnology was first used by Károly Ereky in 1919 to refer to the production of products from raw materials with the aid of living organisms.Medical deviceMedical deviceA medical device is any device intended to be used for medical purposes. In countries around the world, medical devices must be proven safe and effective before they are marketed. As a general rule, the higher the associated risk of the device the more testing is required to establish safety and efficacy. Further, as associated risk increases the potential benefit to the patient must also increase.PharmacovigilancePharmacovigilance (PV, or PhV), also known as drug safety, is the discipline within pharmaceutical science that addresses the identification, evaluation, and mitigation of adverse effects and other drug-related problems associated with pharmaceutical products.Drug developmentDrug developmentDrug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.AssayAn assay is an investigative (analytic) procedure in laboratory medicine, mining, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity. The measured entity is often called the analyte, the measurand, or the target of the assay. The analyte can be a drug, biochemical substance, chemical element or compound, or cell in an organism or organic sample.List of life sciencesList of life sciencesThis list of life sciences comprises the branches of science that involve the scientific study of life — such as animals (including human beings), microorganisms, and plants. This is one of the two major branches of natural science, the other being physical science, which is concerned with non-living matter. Biology is the overall natural science that studies life, with the other life sciences as its sub-disciplines. Some life sciences focus on a specific type of organism.

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